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Physician input improves generative artificial intelligence models’ diagnostic performance in solving complex clinical cases 医生的输入提高了生成式人工智能模型在解决复杂临床病例时的诊断性能。
IF 24.1 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-11-01 DOI: 10.1016/j.landig.2025.100922
Kyle Lam , Julia Calvo Latorre , Andrew Yiu , Grace Navin , Alexander Tan , Jianing Qiu
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引用次数: 0
Synthetic data, synthetic trust: navigating data challenges in the digital revolution 合成数据,合成信任:驾驭数字革命中的数据挑战。
IF 24.1 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-11-01 DOI: 10.1016/j.landig.2025.100924
Arman Koul MS , Deborah Duran PhD , Tina Hernandez-Boussard PhD
In the evolving landscape of artificial intelligence (AI), the assumption that more data lead to better models has driven unchecked reliance on synthetic data to augment training datasets. Although synthetic data address crucial shortages of real-world training data, their overuse might propagate biases, accelerate model degradation, and compromise generalisability across populations. A concerning consequence of the rapid adoption of synthetic data in medical AI is the emergence of synthetic trust—an unwarranted confidence in models trained on artificially generated datasets that fail to preserve clinical validity or demographic realities. In this Viewpoint, we advocate for caution in using synthetic data to train clinical algorithms. We propose actionable safeguards for synthetic medical AI, including standards for training data, fragility testing during development, and deployment disclosures for synthetic origins to ensure end-to-end accountability. These safeguards uphold data integrity and fairness in clinical applications using synthetic data, offering new standards for responsible and equitable use of synthetic data in health care.
在不断发展的人工智能领域,更多的数据会带来更好的模型,这一假设推动了对合成数据的无限制依赖,以增强训练数据集。尽管合成数据解决了现实世界训练数据的严重短缺,但它们的过度使用可能会传播偏见,加速模型退化,并损害整个人群的通用性。在医疗人工智能中快速采用合成数据的一个令人担忧的后果是合成信任的出现——对人工生成的数据集训练的模型的毫无根据的信心,这些数据集未能保持临床有效性或人口统计学现实。在这个观点中,我们提倡谨慎使用合成数据来训练临床算法。我们为合成医疗人工智能提出了可操作的保障措施,包括培训数据标准、开发期间的脆弱性测试和合成来源的部署披露,以确保端到端问责制。这些保障措施维护了使用合成数据的临床应用中的数据完整性和公平性,为在卫生保健中负责任和公平地使用合成数据提供了新的标准。
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引用次数: 0
The impact of artificial intelligence-driven decision support on uncertain antimicrobial prescribing: a randomised, multimethod study 人工智能驱动的决策支持对不确定抗菌素处方的影响:一项随机、多方法研究。
IF 24.1 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-11-01 DOI: 10.1016/j.landig.2025.100912
William J Bolton PhD , Richard Wilson MPharm , Prof Mark Gilchrist MSc , Prof Pantelis Georgiou PhD , Prof Alison Holmes MD , Timothy M Rawson PhD
<div><h3>Background</h3><div>Challenges exist when translating artificial intelligence (AI)-driven clinical decision support systems (CDSSs) from research into health-care settings, particularly in infectious diseases, an area in which behaviour, culture, uncertainty, and frequent absence of a ground truth enhance the complexity of medical decision making. We aimed to evaluate clinicians’ perceptions of an AI CDSS for intravenous-to-oral antibiotic switching and how the system influences their decision making.</div></div><div><h3>Methods</h3><div>This randomised, multimethod study enrolled health-care professionals in the UK who were regularly involved in antibiotic prescribing. Participants were recruited through personal networks and the general email list of the British Infection Association. The first part of the study involved a semistructured interview about participants’ experience of antibiotic prescribing and their perception of AI. The second part used a custom web app to run a clinical vignette experiment: each of the 12 case vignettes consisted of a patient currently receiving intravenous antibiotics, and participants were asked to decide whether or not the patient was suitable for switching to oral antibiotics. Participants were assigned to receive either standard of care (SOC) information, or SOC alongside our previously developed AI-driven CDSS and its explanations, for each vignette across two groups. We assessed differences in participant choices according to the intervention they were assigned, both for each vignette and overall; evaluated the aggregate effect of the CDSS across all switching decisions; and characterised the decision diversity across participants. In the third part of the study, participants completed the system usability scale (SUS) and technology acceptance model (TAM) questionnaires to enable their opinions of the AI CDSS to be assessed.</div></div><div><h3>Findings</h3><div>59 clinicians were directly contacted or responded to recruitment emails, 42 of whom from 23 hospitals in the UK completed the study between April 23, 2024, and Aug 16, 2024. The median age of participants was 39 years (IQR 37–47), 19 (45%) were female and 23 (55%) were male, 26 (62%) were consultants and 16 (38%) were training-grade doctors, and 14 (33%) specialised in infectious diseases. Interviews revealed mixed individualisation of prescribing and uneven use of technology, alongside enthusiasm for AI, which was conditional on evidence and usability but constrained by behavioural inertia and infrastructure limitations. Case vignette completion times and many decisions were equivalent between SOC and CDSS interventions, with clinicians able to identify and ignore incorrect advice. When a statistical difference was observed, the CDSS influenced participants towards not switching (χ<sup>2</sup> 7·73, p=0·0054; logistic regression odds ratio 0·13 [95% CI 0·03–0·50]; p=0·0031). AI explanations were used only 9% of the time when available.
背景:在将人工智能(AI)驱动的临床决策支持系统(cdss)从研究转化为医疗保健环境时存在挑战,特别是在传染病领域,在这个领域,行为、文化、不确定性和经常缺乏基本事实增加了医疗决策的复杂性。我们的目的是评估临床医生对静脉注射到口服抗生素切换的人工智能CDSS的看法,以及该系统如何影响他们的决策。方法:这项随机、多方法研究招募了英国经常参与抗生素处方的卫生保健专业人员。参与者是通过个人网络和英国感染协会的一般电子邮件列表招募的。研究的第一部分包括对参与者的抗生素处方经历和他们对人工智能的看法进行半结构化采访。第二部分使用一个定制的web应用程序来运行一个临床小故事实验:12个病例小故事中的每一个都包括一个目前正在接受静脉注射抗生素的患者,参与者被要求决定该患者是否适合改用口服抗生素。参与者被分配接受标准护理(SOC)信息,或SOC与我们之前开发的人工智能驱动的CDSS及其解释一起接受两组的每个小插曲。我们根据参与者被分配的干预措施评估了他们选择的差异,包括每个小插曲和总体;评估了cds在所有切换决策中的总体效应;并描述了参与者的决策多样性。在研究的第三部分,参与者完成了系统可用性量表(SUS)和技术接受模型(TAM)问卷,以便评估他们对人工智能CDSS的意见。研究结果:直接联系了59名临床医生或回复了招聘电子邮件,其中42名来自英国23家医院,在2024年4月23日至2024年8月16日期间完成了研究。参与者的年龄中位数为39岁(IQR 37-47),女性19人(45%),男性23人(55%),顾问26人(62%),培训级医生16人(38%),传染病专科14人(33%)。采访显示,处方的个性化和技术使用的不均衡,以及对人工智能的热情,这取决于证据和可用性,但受到行为惯性和基础设施限制的限制。在SOC干预和CDSS干预之间,病例小品完成时间和许多决策是相同的,临床医生能够识别和忽略不正确的建议。当观察到有统计学差异时,CDSS影响参与者不切换(χ 2.73, p= 0.0054; logistic回归优势比0.13 [95% CI 0.03 - 0.50]; p= 0.0031)。在可用的情况下,人工智能解释的使用率只有9%。我们的软件和AI CDSS获得了良好的SUS得分,为77.3分(SD为8.79分),TAM问卷的感知有用性得分为3.6分(0.31分),感知易用性得分为3.8分(0.20分),自我效能感得分为4.1分(0.05分)。解释:该AI CDSS得到了积极的接受,并有可能支持抗菌药物处方,当它建议不从静脉注射转为口服治疗时,对临床医生的影响最大。需要进一步的前瞻性研究来收集安全性和获益数据,并了解人工智能cdss进入临床实践后的行为变化。我们的研究表明,人工智能解释可能在护理点上发挥次要作用,人工智能CDSS的采用和利用取决于系统是否易于使用和信任,主要是通过临床证据。资助:英国医疗保健人工智能博士培训研究与创新中心,以及伦敦帝国理工学院国家卫生与护理研究所医疗保健相关感染和抗菌素耐药性卫生保护研究单位。
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引用次数: 0
Label-efficient computational tumour infiltrating lymphocyte assessment in breast cancer (ECTIL): multicentre validation in 2340 patients with breast cancer 标签高效计算肿瘤浸润淋巴细胞评估在乳腺癌(ECTIL): 2340例乳腺癌患者的多中心验证。
IF 24.1 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-11-01 DOI: 10.1016/j.landig.2025.100921
Yoni Schirris MSc , Rosie Voorthuis MSc , Mark Opdam BSc , Marte Liefaard MSc , Prof Gabe S Sonke PhD , Gwen Dackus PhD , Vincent de Jong PhD , Yuwei Wang MSc , Annelot Van Rossum PhD , Tessa G Steenbruggen PhD , Lars C Steggink PhD , Elisabeth G E de Vries PhD , Prof Marc van de Vijver PhD , Roberto Salgado PhD , Efstratios Gavves PhD , Prof Paul J van Diest PhD , Prof Sabine C Linn PhD , Jonas Teuwen PhD , Renee Menezes PhD , Marleen Kok PhD , Hugo M Horlings PhD
<div><h3>Background</h3><div>The density of stromal tumour-infiltrating lymphocytes (TILs) is a prognostic factor for patients with triple-negative breast cancer and reflects their immune response. Computational TIL assessment has the potential to assist pathologists in this labour-intensive task, because it can be quick and reproducible. However, computational TIL assessment models heavily rely on detailed annotations and use complex deep learning pipelines that pose challenges for model iterations and clinical deployment. Here, we propose and validate a fundamentally simpler deep learning-based model that is trained in only 10 min on 100 times fewer pathologist annotations.</div></div><div><h3>Methods</h3><div>We collected whole slide images (WSIs) with TIL scores and clinical data of 2340 patients with breast cancer, including 790 patients with triple-negative breast cancer, from three cohorts in three countries (one each in the USA, UK, and Netherlands) and three randomised clinical trials in the Netherlands. Morphological features were extracted from WSIs using a pathology foundation model. Our model, label-efficient computational stromal TIL assessment (ECTIL), directly regresses the WSI TIL score from these features. We trained ECTIL on a single cohort from The Cancer Genome Atlas (n=356, ECTIL-TCGA), on only triple-negative breast cancer samples from four cohorts (n=400, ECTIL-TNBC), and on all molecular subtypes of five cohorts (n=1964, ECTIL-combined). We computed the concordance between ECTIL and the pathologist using the Pearson's correlation coefficient (<em>r</em>) and computed the area under the receiver operating characteristic curve (AUROC) using the pathologist TIL scores split into the clinically relevant TILs-high (≥30%) and TILs-low (<30%) groups. We also performed multivariate Cox regression analyses on the PARADIGM cohort with complete clinicopathological variables (n=384) to assess hazard ratios for overall survival, independent of clinicopathological factors.</div></div><div><h3>Findings</h3><div>ECTIL-TCGA showed concordance with the pathologist over five heterogeneous external cohorts (<em>r</em>=0·54–0·74, AUROC 0·80–0·94). ECTIL-TNBC showed a higher performance than ECTIL-TCGA on the PARADIGM cohort (<em>r</em> 0·64, AUROC 0·83 <em>vs r</em> 0·58, AUROC 0·80), and ECTIL-combined attained the highest concordance on an external test set (<em>r</em> 0·69, AUROC 0·85). Multivariate cox regression analyses indicated that every 10% increase of ECTIL-combined TIL scores was associated with improved overall survival (hazard ratio 0·85, 95% CI 0·77–0·93; p=0·0007), which was independent of clinicopathological variables and similar to the pathologist score (0·86, 0·81–0·92; p<0·0001).</div></div><div><h3>Interpretation</h3><div>In conclusion, our study showed that ECTIL could score TILs on haematoxylin and eosin-stained, formalin-fixed, paraffin-embedded WSIs in a single step, attaining high concordance with an expert pat
背景:基质肿瘤浸润淋巴细胞(til)的密度是三阴性乳腺癌患者的预后因素,反映了其免疫反应。计算TIL评估有可能帮助病理学家完成这项劳动密集型任务,因为它可以快速且可重复。然而,计算TIL评估模型严重依赖于详细的注释,并使用复杂的深度学习管道,这给模型迭代和临床部署带来了挑战。在这里,我们提出并验证了一个基本更简单的基于深度学习的模型,该模型仅在10分钟内训练了100倍的病理注释。方法:我们收集了2340例乳腺癌患者的全幻灯片图像(wsi)和临床资料,其中包括790例三阴性乳腺癌患者,来自三个国家的三个队列(美国、英国和荷兰各一个)和荷兰的三个随机临床试验。使用病理基础模型提取wsi的形态学特征。我们的模型,标签有效的计算基质TIL评估(ECTIL),直接从这些特征回归WSI TIL评分。我们对来自癌症基因组图谱的单个队列(n=356, ECTIL- tcga)、来自四个队列的三阴性乳腺癌样本(n=400, ECTIL- tnbc)和五个队列的所有分子亚型(n=1964, ECTIL联合)进行了ECTIL训练。我们使用Pearson相关系数(r)计算了ECTIL与病理学家之间的一致性,并使用病理学家TIL评分分为临床相关tils高(≥30%)和tils低(结果:ECTIL- tcga在五个异质外部队列中与病理学家一致(r= 0.54 - 0.74, AUROC为0.80 - 0.94)计算了受试者工作特征曲线下的面积(AUROC)。在范式队列上,ECTIL-TNBC的一致性高于ECTIL-TCGA (r为0.64,AUROC为0.83 vs r为0.58,AUROC为0.80),在外部测试集上,ECTIL-TNBC的一致性最高(r为0.69,AUROC为0.85)。多因素cox回归分析显示,ectil联合TIL评分每增加10%与总生存率提高相关(风险比0.85,95% CI 0.77 ~ 0.93; p= 0.0007),与临床病理变量无关,与病理学评分相似(0.86,0.81 ~ 0.92;综上所述,我们的研究表明,ECTIL可以在血红素和伊红染色、福尔马林固定、石蜡包埋的wsi上一步就得到TILs,与病理学专家的结果高度一致。在不使用基于深度学习的分割和检测管道的情况下,ECTIL在独立于临床病理变量的总体生存分析中获得了与病理学家评分相似的风险比。在未来,这种计算TIL评估模型可用于三阴性乳腺癌患者前瞻性降级试验的预筛选患者,或作为协助病理学家和临床医生对乳腺癌患者进行诊断调查的工具。此外,我们的模型在开源许可下可以在线获得,允许转化研究人员在未来的乳腺癌或其他癌症研究中验证和使用ECTIL。资助:荷兰癌症协会;荷兰卫生、福利和体育部;健康-荷兰,顶级行业生命科学与健康。
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引用次数: 0
Independent and openly reported head-to-head comparative validation studies of AI medical devices: a necessary step towards safe and responsible clinical AI deployment 独立和公开报告的人工智能医疗设备面对面比较验证研究:朝着安全和负责任的人工智能临床部署迈出的必要一步。
IF 24.1 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-11-01 DOI: 10.1016/j.landig.2025.100915
Charles R Cleland , Adnan Tufail , Catherine Egan , Xiaoxuan Liu , Alastair K Denniston , Alicja Rudnicka , Christopher G Owen , Covadonga Bascaran , Matthew J Burton
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引用次数: 0
Correction to Lancet Digital Health 2025; 7: 100866. 《柳叶刀数字健康2025》修正;7: 100866。
IF 24.1 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-10-28 DOI: 10.1016/j.landig.2025.100930
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引用次数: 0
Leveraging digital technologies to reduce cancer disparities in low-income and middle-income countries 利用数字技术缩小低收入和中等收入国家的癌症差距。
IF 24.1 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-10-01 DOI: 10.1016/j.landig.2025.100937
Judy W Gichoya MD , Rogers Mwavu MS , Frank Minja MD , Nadi Kaonga MD PhD , Saptarshi Purkayastha PhD , Janice Newsome MD
In a rural clinic in southwestern Uganda, Dr Sarah examines cervical images on her smartphone, receiving real-time artificial intelligence-powered guidance from a gynaecologic oncologist located hundreds of miles away. Once imaginary, this scenario now represents a highly probable future of digital health innovation transforming cancer care globally. With over 35 million new cases of cancer estimated by 2050, and up to 70% of deaths anticipated to disproportionately occur in low-income and middle-income countries (LMICs), digital solutions can be leveraged to accelerate the closure of these cancer care gaps. The global oncology community has responded to this imminent crisis by proposing several interventions, including promoting workforce education, mentorship, and task shifting; supporting early diagnosis and referrals through integrated diagnostics; prioritising and implementing prevention strategies such as tobacco cessation, cervical cancer screening, and vaccination; standardising and personalising treatment through increased participation in clinical trials and provision of essential cancer medications; and strengthening health-care systems. Across all these strategic pillars, digital health tools are crucial for advancing cancer care and narrowing existing global and geographical disparities in LMICs. In this Series paper, we evaluate the current status of these digital innovations in the context of cancer care.
在乌干达西南部的一家乡村诊所里,Sarah医生用智能手机检查宫颈图像,并接受数百英里外妇科肿瘤学家的实时人工智能指导。这一场景曾经是想象出来的,但现在它代表了数字健康创新极有可能改变全球癌症治疗的未来。到2050年,估计将有3500多万新发癌症病例,高达70%的死亡预计将不成比例地发生在低收入和中等收入国家,因此可以利用数字解决方案来加速缩小这些癌症治疗差距。全球肿瘤学界对这一迫在眉睫的危机做出了回应,提出了一些干预措施,包括促进劳动力教育、指导和任务转移;通过综合诊断支持早期诊断和转诊;优先考虑并实施戒烟、宫颈癌筛查和疫苗接种等预防战略;通过增加参与临床试验和提供基本癌症药物,使治疗标准化和个性化;加强卫生保健系统。在所有这些战略支柱中,数字卫生工具对于推进癌症治疗和缩小中低收入国家现有的全球和地域差距至关重要。在本系列论文中,我们评估了这些数字创新在癌症治疗方面的现状。
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引用次数: 0
Application of artificial intelligence and digital tools in cancer pathology 人工智能和数字工具在癌症病理学中的应用。
IF 24.1 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-10-01 DOI: 10.1016/j.landig.2025.100933
Lawrence A Shaktah MS , Zunamys I Carrero PhD , Katherine Jane Hewitt MBChB , Marco Gustav MSc , Matthew Cecchini MD PhD , Sebastian Foersch MD , Sabina Berezowska MD , Prof Jakob Nikolas Kather MD
Artificial intelligence (AI) is on the verge of reshaping cancer diagnostics through integration into digital pathology workflows. Despite the progression of AI towards real-world deployment, challenges in interpretability, validation, and clinical integration persist. AI models support the interpretation of stains including haematoxylin and eosin, enabling tumour classification, grading, and biomarker quantification, with clinical applications for targets such as HER2 and PD-L1. In addition, AI models enable the quantification of subtle microscopic patterns with prognostic and predictive values across tumour types. Herein, we provide an overview of the applications of AI in pathology and address emerging regulatory and ethical considerations. We also discuss the disparities in adoption across care settings and emphasise the importance of validation, human oversight, and post-deployment monitoring for the responsible implementation of AI in pathology-driven workflows. Furthermore, we highlight the technical advancements driving these developments, particularly the transition from hand-crafted machine learning workflows to deep learning, self-supervised learning for foundation models, multimodal models, and agentic AI.
人工智能(AI)即将通过整合到数字病理工作流程中来重塑癌症诊断。尽管人工智能在现实世界中的应用取得了进展,但在可解释性、验证性和临床整合方面的挑战仍然存在。人工智能模型支持解释包括血红素和伊红在内的染色,实现肿瘤分类、分级和生物标志物量化,并在临床应用于HER2和PD-L1等靶点。此外,人工智能模型能够量化细微的微观模式,具有跨肿瘤类型的预后和预测价值。在此,我们概述了人工智能在病理学中的应用,并解决了新兴的监管和伦理问题。我们还讨论了在不同护理环境中采用人工智能的差异,并强调了在病理驱动的工作流程中负责任地实施人工智能的验证、人为监督和部署后监测的重要性。此外,我们强调了推动这些发展的技术进步,特别是从手工机器学习工作流程到深度学习、基础模型的自监督学习、多模态模型和代理人工智能的转变。
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引用次数: 0
Transforming liver care with artificial intelligence 用人工智能改造肝脏护理
IF 24.1 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-10-01 DOI: 10.1016/j.landig.2025.100948
The Lancet Digital Health
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引用次数: 0
Digital cognitive behavioural self-management programme for fatigue, pain, and faecal incontinence in inflammatory bowel disease (IBD-BOOST): a multicentre, parallel, randomised controlled trial 炎症性肠病患者疲劳、疼痛和大便失禁的数字认知行为自我管理程序(IBD-BOOST):一项多中心、平行、随机对照试验
IF 24.1 1区 医学 Q1 MEDICAL INFORMATICS Pub Date : 2025-10-01 DOI: 10.1016/j.landig.2025.100906
Prof Rona Moss-Morris PhD , Prof Christine Norton PhD , Prof Ailsa Hart PhD , Fionn Cléirigh Büttner PhD , Thomas Hamborg MSc , Laura Miller BSc , Imogen Stagg MSc , Prof Qasim Aziz PhD , Wladyslawa Czuber-Dochan PhD , Prof Lesley Dibley PhD , Megan English-Stevens , Julie Flowers , Serena McGuinness MSc , Prof Borislava Mihaylova DPhil , Prof Richard Pollok PhD , Chris Roukas MSc , Prof Sonia Saxena MD , Louise Sweeney PhD , Prof Stephanie Taylor MD , Vari Wileman PhD

Background

Fatigue, pain, and faecal urgency or incontinence are common, debilitating symptoms in inflammatory bowel disease (IBD). We developed IBD-BOOST, a digital, interactive, facilitator-supported, self-management intervention, and aimed to assess its effects compared with care as usual in relieving these symptoms and improving quality of life.

Methods

This multicentre, parallel, randomised controlled trial was conducted online in the UK, with allocation concealment maintained. Participants aged 18 years or older with IBD who rated the impact of fatigue, pain, and faecal urgency or incontinence as 5 or more on a 0–10 scale in a UK national survey were invited. Participants were randomly assigned (1:1) to the online IBD-BOOST programme or care as usual for 6 months via computer-generated randomisation. Primary outcomes were UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) and Global Rating of Symptom Relief at 6 months post-randomisation. All randomly assigned participants were included in the intention-to-treat and harms analysis. This trial is registered with ISRCTN.com (ISRCTN71618461) and is closed.

Findings

Between Jan 20, 2020, and July 27, 2022, 4449 participants were invited to participate, and 780 participants were randomly assigned: 391 to IBD-BOOST and 389 to care as usual. 524 (67%) of 780 participants were female and 253 (32%) were male. At 6 months, there were no statistically significant differences for UK-IBDQ between the care as usual group (unadjusted mean 62·09 [SD 14·42]) and the IBD-BOOST group (unadjusted mean 60·85 [SD 16·08]; treatment effect estimate: adjusted mean difference –1·67 [95% CI –4·13 to 0·80], p=0·19) or for Global Rating of Symptom Relief (unadjusted mean 3·65 [2·75] vs 4·13 [2·81]; adjusted mean difference 0·44 [95% CI –0·56 to 1·44], p=0·39). Complier-averaged causal effects analysis demonstrated that participants who complied with IBD-BOOST reported lower UK-IBDQ scores than those who would have complied in the care as usual group (mean difference –2·39 [95%CI –4·34 to –0·45], p=0·016). Adverse events and serious adverse events were similar between the IBD-BOOST group (55 [14%] of 391) and care as usual group (79 [20%] of 389). There was one possible treatment-related serious adverse event in the IBD-BOOST group (recurrent sleep disorder) and no deaths.

Interpretation

IBD-BOOST did not statistically significantly improve disease-specific quality of life or Global Rating of Symptom Relief in patients with IBD with fatigue, pain, or faecal urgency or incontinence compared with care as usual. People who complied with the intervention appeared to derive benefit. Future research should focus on enhancing compliance with interventions and targeting them to individuals most likely to benefit.

Funding

UK National Institute for Health and Care Research.
背景:炎症性肠病(IBD)常见的衰弱症状是疲劳、疼痛、大便急迫或大小便失禁。我们开发了IBD-BOOST,这是一种数字化、互动式、辅助工具支持的自我管理干预,旨在评估其与常规护理相比在缓解这些症状和改善生活质量方面的效果。方法:该多中心、平行、随机对照试验在英国在线进行,分配保密。在英国的一项全国性调查中,年龄在18岁或以上的IBD患者将疲劳、疼痛、大便急促或大小便失禁的影响评定为5分或以上(0-10分)。通过计算机生成的随机化,参与者被随机分配(1:1)到在线IBD-BOOST项目或像往常一样护理6个月。主要结局是英国炎症性肠病问卷调查(UK- ibdq)和随机分组后6个月症状缓解的全球评分。所有随机分配的参与者都被纳入意向治疗和危害分析。该试验已在ISRCTN.com注册(ISRCTN71618461),目前已结束。研究结果:在2020年1月20日至2022年7月27日期间,4449名参与者被邀请参加,780名参与者被随机分配:391名参与者接受IBD-BOOST治疗,389名接受常规护理。780名参与者中有524名(67%)是女性,253名(32%)是男性。6个月时,照护组(未校正平均值62.09 [SD 14.42])与IBD-BOOST组(未校正平均值605.85 [SD 16.08];治疗效果估计:校正平均差值- 1.67 [95% CI - 4.13至0.80],p= 0.19)或症状缓解总体评分(未校正平均值3.65[2.75]对4.13[2.81];校正平均差值0.44 [95% CI - 0.56至1.44],p= 0.39)之间无统计学差异。编者平均因果效应分析表明,遵守IBD-BOOST的参与者报告的UK-IBDQ得分低于照护组(平均差值为-2·39 [95%CI - 4.34至- 0.45],p= 0.016)。不良事件和严重不良事件在IBD-BOOST组(391例中55例[14%])和常规护理组(389例中79例[20%])之间相似。IBD-BOOST组有1例可能与治疗相关的严重不良事件(复发性睡眠障碍),无死亡。解释:与常规治疗相比,IBD- boost对伴有疲劳、疼痛、大便急症或尿失禁的IBD患者的疾病特异性生活质量或症状缓解的全球评分没有统计学意义上的显著改善。遵守干预措施的人似乎从中获益。未来的研究应侧重于加强对干预措施的依从性,并针对最有可能受益的个人。资助:英国国家卫生和保健研究所。
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Lancet Digital Health
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